Non-invasive Tissue Retractor

ABSTRACT

A device for retracting or opening and closing a tissue wound employs two or more retractor arms that do not enter or penetrate into the wound or incision. The retractor arms engage the tissue on either side of the wound and apply outward or inward pressure on the tissue surface to open or close the wound.

1. BACKGROUND OF THE INVENTION Field of the Invention

In the medical sector, there are many cases where wounds and incisions must be held open or closed for medical procedures and surgeries. Many times these wounds are small to medium in size, relatively shallow and in extremely difficult areas where there is very little room to retract the wound to perform the needed medical procedure. The I 2X is the only noninvasive retractor to be able to perform retraction or closing in extremely tight environments such as fingers between fingers, toes and between toes, ears, certain body cavities and openings and other hard to reach places. Many retractors look and perform almost identically but are specifically designed for unique and specific operation modality. The I 2X is designed for specific application that no other noninvasive retractor can perform due to its method of operation and overall size profile. No other retractor noninvasively retracts or holds the wound closed for gluing, suturing or other procedures where a wound or incision must be held open or closed without disengaging the retraction device. This new method is extremely critical to a multitude of medical procedures.

DESCRIPTION OF THE PROBLEM AND PRIOR ART

The devise described herein is an advancement over the retractor described in U.S. Pat. No. 9,981,081. Medical practitioners find it extremely difficult to retract and add or close the tissue of wounds and incisions in certain areas of close proximity and involving a variety of medical procedures. An example of this is hand surgery in the areas of the fingers, where it is very difficult to use the current methods of minimally invasive retraction due to fact that there is very little space to work in, plus the invasive nature of the retractor is in the way visually, causes trauma to the wound and makes wound retraction and the process difficult to impossible.

An approach is needed that employs a noninvasive, very low profile, retractor that can perform in extremely tight quarters without entering the wound. The I 2X is the only retractor that can noninvasively perform a prolifera of tasks in this specific and unique manner for very tight surgical environments.

2. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1, FIG. 1a show a partially exploded view of the I 2X Retractor from the top (FIG. 1) and side view (FIG. 1a ) with the arm positioning sleeve (19) closing and retaining the wound closed (16, 17).

FIG. 2 shows the I 2X Retractor's interior upper loop screwed into the threads of a luer lock (5) on an Interceptor medical device. This is an example of the I 2X being used as an accessory to another medical device, using its interior upper loop end to engage a luer lock thread. In some cases, an I 2X would have a male luer lock thread as part of the upper loop at the interior end to engage the female component luer lock.

FIG. 3 shows the I 2X screwed into and engaged into a luer lock of a standard plunger type syringe (13, 11). In this view, the I 2X is being used to retract or close, by use of an arm positioning sleeve, the wound noninvasively, making use of an adhesive surgical tape (19) as an anchoring device (14) on the distal left-hand side and being anchored on the distal right-hand side by a pin placed into the tissue (15).

FIG. 4 shows the I 2X Retractor in a standalone, hands free open mode. In this view, the I 2X Retractor is not employed as an accessory to another device. The view in FIG. 4 depicts the Retractor making use of anchoring methods (14, 15) to open or close (if the arm positioning sleeve is added) and retain the position and topography of a wound in a confined operating environment in a unique noninvasive manner.

FIG. 5 shows the flexibility of the I 2X to make use of more than two arms to perform specific retraction or closing methods. In this view, the I 2X is connected and screwed into a luer lock, which implies that it is being used as an accessory to another medical device, such as a syringe, an Interceptor or some other medical device employing the use of a luer lock to accommodate I 2X noninvasive retraction or wound closure.

FIG. 6 shows the arms (8) extended outward and the mechanism at the distal end (2) engaging the tissue, which needs to be moved, retracted or repositioned in an inward or outward manner. The figure also depicts I 2X possessing a male luer lock as opposed to a loop at the anterior end.

3. DETAILED DESCRIPTION OF THE INVENTION Definitions

In the following description of the invention, DISTAL refers to the end of the device or its parts that will be closest to the sight of the application against the skin during use. In the following description of the invention, ANTERIOR refers to the end of the device or its parts that will be furthest from the sight of application against the skin during use.

Description

The present invention provides an I 2X device and method by which certain difficult to reach wounds may be accessed and noninvasively retracted or closed for medical surgery and procedures. The present invention provides a tissue retractor or closer (1) that may be used to open and hold open or close and retain closed small wounds or incisions. In the figures, like numbers denote the same parts. The I 2X (1) is, in part, comprised of a continual single strand of fabricated material wire like in nature and, in many cases, this single strand of fabricated material is medical grade stainless steel but not in every case. This single strand of spring like material undergoes a series of bends. These bends serve a specific purpose, starting with the partial loop-like bend (7) at the anterior end of the device which is fabricated and pitched to accommodate the threads of a luer lock device, which is found to be employed by medical devices such as common syringes. The loop (7) at the anterior end of the device extends on both sides downward to make an arm assembly (8). This arm assembly (8) accommodates spring-like action with the inclination to spring or expand outward (or by use of its arm positioning sleeve be limited to a more closed position) but with a spring-like propensity in an outward direction from its central location to pull a wound or incision in an outward or open manner (FIG. 3). Partway down the arm (8) of the I 2X can be found an alternative coil, which in part is the continuation of the arm itself in a coiled manner. This coil (3), if added to the device as an alternative, accommodates certain specific needs and creates a shift in vector and pitch to the action and motion of the arm (8). At the furthest distal point of the I 2X is found a bend in the arm (2) somewhat below the optional coil (3) to accommodate skin contact and friction or anchoring alternatives.

As the I 2X is applied to the wound area (16), the ends of the spreader arms (2) contact the skin (18) first and then spread outwards from wound (16), pulling the skin around the wound slightly taut, thereby tightening or retracting the skin away from the wound. In FIG. 5, a greater or lesser number of spreader arms (8, 8 a) may be used. The important feature is that the spreader arms result in forming or positioning the wound opening to permit a more efficient operation and better accessibility because the device does not enter the wound or incision to hold it opened or closed. At the same time, this tightening in a direction away from the center of the wound allows for a puckering (17) at the edge of the wound (16), which allows for pooling of antiseptic for high concentration applications, for example. This retraction method is accomplished in a unique, low profile, noninvasive method. In an alternative embodiment, shown in FIG. 3, the spreader arms at the anterior end (7) has engaged a female luer lock thread, fastening itself to the distal end of a syringe. The female luer lock (5) engages the anterior end of I 2X by use of the bend (7) at the anterior end as I 2X engages and screws into the threads of said luer lock, which is in part the distal end of the syringe (11) containing the piston plunger (13) and nozzle (4). This embodiment (FIG. 3) is yet another example of the Retractor I 2X being used as an accessory to a medical device. Under the above circumstances, this method may be used to maintain a wound open for irrigation and flushing of debris or pathogens, internal application of epinephrine or lidocaine, manual removal of debris from a wound, surgical application requiring alternate medication drips administered to the wound. The device may be unscrewed and disengaged from the medical device it was used with as an accessory and then become a hands free, standalone retractor with extremely low profile and noninvasive attributes for specific applications, noted in FIG. 4. As seen in the embodiment in FIG. 1, FIG. 1A and FIG. 5, the I 2X Spreader Retractor utilizes two or more spreader arms (8) substantially located 180 degrees apart on opposite sides. It is important that the arms be located opposite each other to work against each other to retract the wound or incision equally from both sides of the wound (16). In addition to the restoring action of the optional coils (3), the material from which the long spreader arms are made of also provides additional resilience to the displacement. Arms (8) made with material with greater resistance to displacement may be employed, depending on the spreading force requirement for particular wound, incisions and methodology. Typically, the arms are formed from stainless steel, which may be disinfected or sterilized so that the Retractor may be used in a variety of medical settings to sustain long-term opening or closing of a wound or incision.

The spreader arms (8) may be anchored to the tissue surface (18) by means of, but not limited to, adhesive strips, pins, adhesives, and, but not limited to, medical grade glues and fastening devices. The ends/contact surfaces (2) of arms (8) may be adapted to particular anchoring methods, as will be well understood by those skilled in the art. For example, a longer end (2) may be provided for use with adhesive anchoring strips (14) as shown in FIG. 3. Alternatively, an end (2) with a slight hook may be provided to engage a pin (15) as shown in FIG. 3 and FIG. 4. Where appropriate, the anchoring means may be applied to the tissue surface before the retractor arms (8) are engaged. As a further example, the ends/contact surfaces (2) of the spreader arms may be coated with a soft adhesive so that, as they engage the tissue surface, the ends/contact surfaces (2) are anchored to the tissue surface.

In order to use the wound retractor of this application, the longer arms (8) may be pinched together or inwardly by the user, and, after engaging one of the anchoring means, released. The combined resilience of the material of which arms (8) are made in addition to the resilience and vector distribution of the alternative coils (3) provides an outward thrust, thereby opening the wound or incision (16) to the appropriate shape for the intended procedure. Not only do the coils (3) provide additional outward thrust to the arms (8), but they also provide for a change of pitch of the spreader arm (8), providing an outward component away from the plane of the tissue (18) to achieve the desired wound topography. Anchored in this manner, the outward thrust of the spreader arms, indicated by the arrows on the tissue surface in FIG. 3 and FIG. 4, increases as the spreader assembly (1) is moved toward the tissue surface (18), increasing the pressure applied by the spreader retractor (1). Under most circumstances, the optional coils (3) in the spreader arms (8) are essential to enabling the spreader arm ends/contact surfaces to move downward and outward in the desired manner by maintaining outward thrust even as more pressure is exerted by the decreasing distance of the spreader retractor (1). It is to be noted that the only time the device (1) is chosen that does not contain the optional coils (3) or optional arm positioning sleeve (19) is when the space or circumstances in which the I 2X is operating do not allow for the additional area, which is taken up by the coils (3) and, in some cases also, the optional arm positioning sleeve.

Utilized in this manner, the spreader arms (8) position the wound or incision (16) in a specific topography and shape. Unlike prior art retractors, which are larger and must be invasively inserted into a wound, the spreader arm retractors (8) of this embodiment do not intrude into the wound or incision (16). The spreader arm retractor does not just tighten the skin/tissue on either side of the wound or incision but, most importantly, also opens the wound or incision (16) and puckers its shape (17). The outward thrust of the spreader retractor arms (8) causes the wound to take on a specific puckered shape by rotating both tops of the wound or incision walls (17) away from the center of the wound or incision, thereby exposing the base of the wound and more surface area for more thorough access. A topography is developed in which the tops of the wound or incision walls rise above the surrounding tissue surface, thereby permitting debris and pathogens to flow away from the wound base during the flushing and irrigation process. Puckering also raises the base of the wound, which is important for complete flushing and removal of contamination. In many cases, puckering can cause pooling of antiseptics, which can increase concentration if allowed to remain for a given exposure interval. The above process, along with many different surgical and medical procedures, is accomplished without the retractor arms engaging the inside of the wound, which is a unique noninvasive process compared with prior art retractors. This unique noninvasive methodology allows for greater access, less wound trauma and an operational mode which lends itself to being able to perform in tight quarters noninvasively where other retractors cannot. Those skilled in the art will appreciate that various modifications and alterations may be made to the device and method described in this patent document, and such are considered to fall within the scope of this disclosure and appended claims.

COMPONENTS AND DESCRIPTIONS OF INTERCEPTOR 2X (I 2X)

-   1. A device for retracting, opening and closing a tissue wound or     incision (I 2X) -   2. The distal end, foot or hook of the Retractor I 2X -   3. The coil located part way down from the anterior upper end of I     2X -   4. The nozzle associated with a device such as a syringe, for     example -   5. The outer flange of a nozzle and luer lock assembly -   6. The tubular wall of the JRP Wound Spreader Interceptor I -   7. The anterior looped end of the I 2X used to engage the threads of     a luer lock -   8. The arms of the I 2X Retractor     -   a. A Retractor I 2X with multiple arms -   9. The Interceptor I retaining disk for the retractor nozzle     assembly -   10. The orifice to secure the anterior end of the Retractor     (Interceptor I) arm assembly -   11. The walls of a syringe housing -   12. A slip fit syringe nozzle -   13. A syringe piston or plunger -   14. An anchoring device and method -   15. An anchoring pin -   16. A tissue wound or incision -   17. A wound wall section -   18. Tissue or skin -   19. The arm positioning sleeve for wound positioning -   20. A positioned wound -   21. A male luer lock component fixed stationary and part of the     anterior end of I 2X as an alternative to the anterior loop 

The invention claimed is:
 1. A noninvasive retractor apparatus for retracting or closing wounds and incisions, which occur in animal and human tissue.
 2. The retractor of claim 1 having two stiff, but flexible, retractor spreader arms formed from a continuous wirelike strand of material with the two arms positioned substantially 180 degrees apart, extending outward.
 3. The retractor spreader arms of claim 2 having optional spring coils located approximately about half the length of each spreader arm and means at the end of each arm for engaging anchoring means at the skin tissue surface, wherein the spreader arms and optional coils flexibly apply pressure to the skin surface to tighten and retract or to close the skin opening in the immediate area of the wound or incision in a direction outward from the wound or incision's center or an inward direction to close the wound.
 4. The retractor spreader arms of claim 3 in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by adhesive means.
 5. The retractor spreader arms of claim 3 in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by non-slip material.
 6. The retractor spreader arms of claim 3 in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored by mechanical attachment.
 7. A noninvasive retractor apparatus for engaging skin wounds and incisions, having a central support area and making use of a continuous single wire-like strand in a continuous manner as its structure experiences several bends to accommodate its functional shape and purpose.
 8. The retractor of claim 7 having two stiff, but flexible, spreader arms comprised of a continuous wire like strand of material at their first end, leading to their central support area and disposed about the support in positions substantially 180 degrees apart and having a loop in their central support at their first end to accommodate the threads of a luer lock said spreader arms extending beyond the end of the central support and loop.
 9. The retractor spreader arms of claim 8 having means located at the second end of each arm for engaging anchoring means at the skin surface, wherein the spreader arms flexibly apply pressure to the skin surface to tighten and retract or close the wound in the skin in the immediate area of the wound in a direction outward or inward toward the wound center.
 10. The retractor spreader arms of claim 9, in which the optional spring coils are located approximately about half the length of each spreader arm.
 11. The retractor spreader arms of claim 9, in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by adhesive means.
 12. The retractor spreader arms of claim 9, in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by non-slip material.
 13. The retractor spreader arms of claim 9, in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored by mechanical attachment.
 14. A non-invasive retractor apparatus for engaging skin wounds and incisions, comprising a central support area and two pairs of flexible spreader arms, each spreader arm formed from a continuous wire like strand of material, which becomes at their first end a central support area and loop, and each pair is disposed about the support in positions substantially 180 degrees apart.
 15. The retractor spreader arms of claim 14, in which optional spring coils are located approximately about half the length of each spreader arm.
 16. The retractor spreader arms of claim 14, in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by adhesive means.
 17. The retractor spreader arms of claim 14, in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by non-slip material.
 18. The retractor spreader arms of claim 14, in which the means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by mechanical attachment.
 19. The retractor spreader arms of claim 14, in which one spreader arm of each pair is longer than the other spreader arm of the pair.
 20. The retractor spreader arms of claim 19, in which optional spring coils are located approximately about half the length of each spreader arm.
 21. The retractor spreader arms of claim 19, in which means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by adhesive means.
 22. The retractor spreader arms of claim 19, in which means at the ends of each arm for engaging anchoring means are adapted to be anchored in place by non-slip material.
 23. The retractor spreader arms of claim 19 in which means at the ends of each arm for engaging anchoring means are adapted to be anchored by mechanical attachment.
 24. A method of noninvasively spreading a skin tissue wound or incision using the retractor of claim 19, in which the retractor is placed substantially parallel to the skin surface with the shorter spreader arms of each pair placed near the end of the wound or incision closest to the central support and the longer spreader arm placed further away. 